Study Evaluating the Parent-child Relationship During the Hospitalisation of a Parent in Long-term Protective Isolation

NCT04856332 | Completed

• 1 other identifier: ET19-193 - VIK-e2
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 3

Brief Summary

The intensive treatments of certain cancers and haemopathies require the implementation of a protective isolation from external micro-organisms for a period of several weeks. This isolation implies a limitation of visitors and sometimes prohibits access to young children. This raises questions concerning the maintenance of family links, and in particular the parent-child relationship as well as the psychological and emotional isolation of hospitalised patients and the resulting psychological effects.

Conditions

Cancer

Keywords

Cancer; Long-term protective isolation; Patient-child relationship

Outcome Measures

Primary Outcomes (2)

• Evaluation of the use of a telepresence robot on the parent-child relationship in maintaining parenthood during parent's hospitalisation in long-term protective isolation

  Observation of communications between the hospitalised patient and his/her chid(children) by a specialist in human and social sciences

  Through study completion, an average of 3 months

• Evaluation of the use of a telepresence robot on the parent-child relationship in maintaining parenthood during parent's hospitalisation in long-term protective isolation

  Interview with the hospitalised patient (parent) by a specialist in human and social sciences

  Through study completion, an average of 3 months

Secondary Outcomes (5)

• Evaluation of the experience linked to the robot availability on the concerned persons (patient, children, person on charge of children)

  Through study completion, an average of 3 months

• Evaluation of patient's satisfaction

  Through study completion, an average of 3 months

• Evaluation of the impact of robot use on patient's coping strategies (adaptation and adjustment to illness and hospitalisation)

  Through study completion, an average of 3 months

• Evaluation of patient's experience of hospitalisation

  Through study completion, an average of 3 months

• Evaluation of the impact of the robot's presence at home on the children and the person in charge of the children during patient's hospitalisation

  Through study completion, an average of 3 months

Interventions

Telepresence robot installed at child's home during parent's hospitalisation OTHER

Telepresence robot installed at child's home during parent's hospitalisation in long term protective isolation for maintaining parent-child ink (only children aged 15 years or less are concerned)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Observational prospective study, multicenter of parent-child relationship assessment following the setting up of a mobile telepresence robot for patients with children aged 15 years or less and hospitalised in long-term protective isolation. This study is based on semi-directed interviews and observations made during patient's hospitalisation and when patient returns at home.

You may qualify if:

• Age≥ 18
• Patient with at least one child aged 15 or under
• Pathology requiring a prolonged hospitalization in protective isolation
• Consent dated and signed

You may not qualify if:

• Impaired cognitive functions
• Performance Status -Eastern Cooperative Oncology Group (PS-ECOG) = 4
• Difficulties in speaking and understanding French
• Patient under guardianship or curatorship

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (3)

Centre Leon Berard

Lyon, 69008, France

Location

Centre Hospitalier Lyon Sud

Lyon, France

Location

Institut Paoli Calmettes

Marseille, 13000, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• GUILLERMIN Yann, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 23, 2021
• Study Start: February 24, 2021
• Primary Completion: June 3, 2023
• Study Completion: June 3, 2023
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

FR (3)